FDA Approves Balversa (erdafitinib) for the Treatment of Metastatic Bladder Cancer
April 12, 2019 -- The U.S. Food and Drug Administration today granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 13, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Evenity (romosozumab-aqqg) for the Treatment of Osteoporosis in Postmenopausal Women at High Risk of Fracture
April 9, 2019 -- The U.S. Food and Drug Administration today approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture). These are women with a history of osteoporotic fracture or... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 9, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Dovato (dolutegravir/lamivudine) for HIV-1 Infection
LONDON--(BUSINESS WIRE) April 08, 2019 --ViiV Healthcare today announced that the US Food and Drug Administration (FDA) approved Dovato, a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 9, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ibrance (palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Breast Cancer
April 4, 2019 -- Pfizer (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indications for Ibrance (palbociclib) in combination with an aromatase inhibitor or... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 4, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Avaclyr (acyclovir ophthalmic ointment) for the Treatment of Herpetic Keratitis
NEW YORK–(BUSINESS WIRE) April 01, 2019–The US Food and Drug Administration (FDA) has approved Fera Pharmaceuticals' New Drug Application (NDA) for Avaclyr (acyclovir ophthalmic ointment) 3% for the treatment of herpetic keratitis.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 2, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves the Reintroduction of Zelnorm (tegaserod) for Irritable Bowel Syndrome with Constipation (IBS-C) in Women Under 65
LOUISVILLE, Ken., April 1, 2019 /PRNewswire/ -- US WorldMeds has announced that Sloan Pharma, S.a.r.l., a subsidiary of US WorldMeds Holdings, LLC, has received approval from the U.S. Food and Drug Administration (FDA) for the reintroduction of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 1, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Asceniv (immune globulin intravenous, human) for Primary Humoral Immunodeficiency
RAMSEY, N.J. and BOCA RATON, Fla., April 01, 2019 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the“Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 1, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Duaklir Pressair (aclidinium bromide and formoterol fumarate) for Maintenance Treatment of Chronic Obstructive Pulmonary Disease
Oxford, UK– 1 April 2019: Circassia Pharmaceuticals plc (“Circassia” or“the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the US Food and Drug Administration... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 1, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Mavenclad (cladribine) Tablets for Multiple Sclerosis
March 29, 2019 -- The U.S. Food and Drug Administration today approved Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting disease and active secondary progressive disease.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 30, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Cimzia (certolizumab pegol) for the Treatment for Non-Radiographic Axial Spondyloarthritis
Brussels, Belgium– 29 March 2019– UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved extending the label for Cimzia (certolizumab pegol) to include a new indication... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 29, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Jatenzo (testosterone undecanoate) for Certain Forms of Hypogonadism
March 27, 2019 -- The U.S. Food and Drug Administration today approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. These men have low testosterone levels due to specific medical... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 27, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Mayzent (siponimod) for Secondary Progressive Multiple Sclerosis
Basel, March 27, 2019 - Novartis today announced that the US Food and Drug Administration (FDA) has approved Mayzent (siponimod) for the treatment of adults with relapsing forms of multiple sclerosis, including secondary progressive multiple... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 27, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Sunosi (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
DUBLIN, March 20, 2019 /PRNewswire/ -- Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) approved Sunosi (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 21, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Zulresso (brexanolone) for the Treatment of Postpartum Depression
March 19, 2019 -- The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 19, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Genentech ’s Tecentriq in Combination With Chemotherapy for the Initial Treatment of Adults With Extensive-Stage Small Cell Lung Cancer
South San Francisco, CA -- March 18, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq (atezolizumab), in combination with carboplatin and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 18, 2019 Category: Drugs & Pharmacology Source Type: news

Allergan Announces FDA Approval of Avycaz (ceftazidime and avibactam) for Pediatric Patients
DUBLIN, March 18, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) for Avycaz (ceftazidime and avibactam),... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 18, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Rocklatan (netarsudil and latanoprost ophthalmic solution) for the Reduction of Intraocular Pressure in Open-Angle Glaucoma or Ocular Hypertension
DURHAM, N.C.--(BUSINESS WIRE)--Mar. 12, 2019-- Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie or the Company), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 12, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Atopic Dermatitis in Adolescents
CAMBRIDGE, Mass. and TARRYTOWN, N.Y., March 11, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 11, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Trazimera (trastuzumab-qyyp), a Biosimilar to Herceptin
March 11, 2019 - Pfizer Inc. today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab),1 for the treatment of human epidermal growth factor... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 11, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Grants Genentech ’s Tecentriq in Combination With Abraxane Accelerated Approval for People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer
South San Francisco, CA -- March 8, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq (atezolizumab) plus... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 8, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Spravato (esketamine) Nasal Spray for Treatment-Resistant Depression
March 5, 2019 -- The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 5, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Adhansia XR (methylphenidate hydrochloride) Extended-Release Capsules for the Treatment of ADHD
STAMFORD, Conn.--(BUSINESS WIRE) March 01, 2019 --Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P., announced that the U.S. Food and Drug Administration (FDA) approved Adhansia XR (methylphenidate hydrochloride) extended-release capsules... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 1, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers
South San Francisco, CA -- February 28, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 28, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Tremfya (guselkumab) One-Press Patient-Controlled Injector for Adults with Moderate-to-Severe Plaque Psoriasis
HORSHAM, PENNSYLVANIA, February 27, 2019 - The Janssen Pharmaceutical Companies of Johnson& Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya One-Press, a single-dose, patient-controlled injector for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 27, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Expands Indication for Soliqua 100/33 (insulin glargine and lixisenatide injection) to Include Type 2 Diabetes Patients Uncontrolled on Oral Antidiabetic Medicines
BRIDGEWATER, N.J., Feb. 27, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved the expanded use of Soliqua 100/33 (insulin glargine and lixisenatide injection) 100 Units/mL and 33 mcg/mL. Previously approved for use as an... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 27, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Supplemental New Drug Application to Expand Cinvanti (aprepitant) Label for IV Push
SAN DIEGO, Feb. 26, 2019 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 26, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Gloperba (colchicine) for Prophylaxis of Adult Gout Flares
WOBURN, Mass.--(BUSINESS WIRE)--February 26, 2019 ROMEG Therapeutics, an innovative drug development company focused on alternative formulations to better meet clinical and patient needs, today announced that the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 26, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Lonsurf (trifluridine/tipiracil) for Adult Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
PRINCETON, N.J., February 25, 2019– Taiho Oncology, Inc. today announced that the United States Food and Drug Administration (FDA) has approved Lonsurf as a treatment for adult patients with metastatic gastric or gastroesophageal junction... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 25, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Esperoct (turoctocog alfa pegol, N8-GP) for Hemophilia A
Bagsværd, Denmark, 19 February 2019 - Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application for Esperoct for the treatment of adults and children with hemophilia A. Esperoct... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 20, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Keytruda (pembrolizumab) for the Adjuvant Treatment of Patients with Melanoma with Involvement of Lymph Node(s) Following Complete Resection
KENILWORTH, N.J.--(BUSINESS WIRE) February 19, 2019 --Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 20, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Egaten (triclabendazole) for the Treatment of Fascioliasis, a Neglected Tropical Disease
Basel, Switzerland, February 13, 2019 - Novartis announced today that the US Food and Drug Administration (FDA) has approved Egaten (triclabendazole) for the treatment of fascioliasis in patients six years of age and older. This makes Egaten the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 13, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Darzalex (daratumumab) Split-Dosing Regimen
Horsham, PA, February 12, 2019– The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved a split-dosing regimen for Darzalex® (daratumumab), providing... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 12, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Cablivi (caplacizumab-yhdp) for Acquired Thrombotic Thrombocytopenic Purpura (aTTP) in Adults
February 6, 2019 -- The U.S. Food and Drug Administration today approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 6, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Jeuveau (prabotulinumtoxinA-xvfs) for Temporary Improvement in the Appearance of Frown Lines
NEWPORT BEACH, Calif., Feb. 01, 2019 (GLOBE NEWSWIRE) -- Evolus, Inc. (NASDAQ: EOLS) today announced that the U.S. Food and Drug Administration (“FDA”) has approved its lead product, Jeuveau, for the temporary improvement in the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 1, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), First Generic of Advair Diskus
HERTFORDSHIRE, England and PITTSBURGH, Jan. 31, 2019 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) today announced the U.S. Food and Drug Administration (FDA) approval of Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 31, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Osphena (ospemifene) for Moderate to Severe Vaginal Dryness Due to Menopause
BLAINVILLE, QC, January 29, 2019– Duchesnay Inc., a pharmaceutical company specializing in women’s health, announced today that the FDA has approved its supplemental New Drug Application (sNDA) seeking to add moderate to severe vaginal... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 29, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Imbruvica (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Na ïve Patients with Chronic Lymphocytic Leukemia
HORSHAM, Pa., Jan. 28, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson& Johnson announced today the U.S. Food and Drug Administration (FDA) approval of Imbruvica (ibrutinib) in combination with obinutuzumab in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 28, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Tosymra (sumatriptan) Nasal Spray for Acute Treatment of Migraine
January 27, 2019 -- Dr. Reddy’s Laboratories Ltd. and its subsidiary, Promius Pharma, LLC today announced the approval of Tosymra (previously known as DFN-02) by the U.S. Food and Drug Administration (FDA). Tosymra is indicated for the acute... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 27, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Use of 0.5 mL Dose of Fluzone Quadrivalent (influenza vaccine) in Children as Young as 6 Months of Age
BRIDGEWATER, N.J., Jan. 23, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration has approved the use of the 0.5 mL dose of Fluzone Quadrivalent (influenza vaccine) to include children age 6 through 35 months. Sanofi Pasteur, the vaccine... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 23, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin
January 18, 2019 -- FDA today approved Ontruzant (trastuzumab-dttb), a biosimilar to U.S.-licensed Herceptin (trastuzumab). A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-FDA... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 18, 2019 Category: Drugs & Pharmacology Source Type: news

Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) Tablets for Previously Treated Hepatocellular Carcinoma
ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 14, 2019-- Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved Cabometyx (cabozantinib) tablets for patients with hepatocellular carcinoma (HCC) who have been... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 14, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Expanded Use of Adacel (Tdap) Vaccine for Repeat Vaccination
BRIDGEWATER, N.J., Jan. 14, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration has approved the expanded use of Adacel® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Adsorbed) to include repeat... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 14, 2019 Category: Drugs & Pharmacology Source Type: news

KemPharm Announces FDA Approval of sNDA for Two Additional Strengths of Apadaz (4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP)
CORALVILLE, Iowa, Jan. 07, 2019 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced today that the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 8, 2019 Category: Drugs & Pharmacology Source Type: news

Sprycel (dasatinib) Tablets Now Approved in Combination with Chemotherapy in Certain Pediatric Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel® (dasatinib) tablets to include the treatment of pediatric patients... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 3, 2019 Category: Drugs & Pharmacology Source Type: news

Horizon Pharma plc Announces FDA Approval to Expand the Age Range for Ravicti (glycerol phenylbutyrate) Oral Liquid to Include Newborns
DUBLIN--(BUSINESS WIRE)--Dec. 27, 2018-- Horizon Pharma plc (NASDAQ: HZNP) today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to expand the age range for Ravicti (glycerol... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 27, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Vaxelis Pediatric Hexavalent Combination Vaccine
BRIDGEWATER, N.J. and KENILWORTH, N.J.– December 26, 2018–The U.S. Food and Drug Administration has approved Vaxelis™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 27, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves ProAir Digihaler (albuterol sulfate) as the First and Only Digital Inhaler with Built-In Sensors
JERUSALEM--(BUSINESS WIRE)--Dec 21, 2018--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved ProAir® Digihaler™ (albuterol sulfate 117 mcg) inhalation... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 22, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Inbrija (levodopa inhalation powder) for Intermittent Treatment of OFF Episodes in People with Parkinson ’s Disease
ARDSLEY, N.Y.--(BUSINESS WIRE) December 21, 2018 --Acorda Therapeutics, Inc. today announced that the U.S. Food and Drug Administration approved Inbrija™ for intermittent treatment of OFF episodes in people with Parkinson’s disease... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Elzonris (tagraxofusp-erzs), the First Treatment for Blastic Plasmacytoid Dendritic Cell Neoplasm and First CD123-Targeted Therapy
NEW YORK, December 21, 2018 (GLOBE NEWSWIRE)– Stemline Therapeutics, Inc. (NASDAQ:STML), a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, announced today that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ultomiris (ravulizumab-cwvz) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)
BOSTON--(BUSINESS WIRE)-- December 21, 2018 -- Alexion Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab-cwvz), the first and only long-acting C5 complement inhibitor... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 21, 2018 Category: Drugs & Pharmacology Source Type: news